• 14/30288421 DC : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN ISO/IEC 80369-6 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-04-2016

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Dimensional requirements for SMALL-BORE CONNECTORS
      for neuraxial APPLICATIONS
    6 Performance requirements
    Annex A (informative) - Rationale and guidance
    ANNEX B (normative) - SMALL-BORE CONNECTORS for neuraxial
            APPLICATIONS
    ANNEX C (normative) - Reference CONNECTORS for testing SMALL-BORE
            CONNECTORS for neuraxial APPLICATIONS
    Annex D (informative) - Assessment of MEDICAL DEVICES and their
            attributes with CONNECTIONS within this APPLICATION
    ANNEX E (informative) - Summary of the usability requirements for
            SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
    Annex F (informative) - Summary of SMALL-BORE CONNECTOR criteria
            and requirements for neuraxial APPLICATIONS
    ANNEX G (informative) - Summary of assessment of the design of the
            SMALL BORE CONNECTORS for neuraxial APPLICATIONS
    Annex H (informative) - Mechanical tests for verifying
            NON-INTERCONNECTABLE characteristics
    Annex I (informative) - Reference to the Essential Principles
    Bibliography
    Terminology - Alphabetized index of defined terms
    Annex ZA (informative) - Relationship between this Document and
             the Essential Requirements of EU Directive 93/42/EEC

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/210/5
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 3040:2016 Geometrical product specifications (GPS) Dimensioning and tolerancing Cones
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
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